{ "schema_version": 1, "kind": "condition", "id": "ankylosing-spondylitis-referral", "name": "Ankylosing spondylitis (referral & NSAID symptom control)", "category": "chronic", "sources": "Naproxen 500 mg Tablets SmPC section 4.2 (eMC product 2639) · eMC SmPC, Arcoxia 90 mg film-coated tablets (Organon), sections 4.1 and 4.2 · Celecoxib US prescribing information, Dosage and Administration (DailyMed SetID 2c86ece8-1cf5-4688-91b1-8aef5d60b7e4) · Wenker KJ, Quint JM. Ankylosing Spondylitis. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Bookshelf ID: NBK470173. PMID: 29261996. · Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986) · Enbrel 50mg solution for injection in pre-filled syringe SmPC sections 4.1, 4.2 and 4.3 (eMC product 273) · Remsima 100 mg powder for concentrate for solution for infusion (infliximab) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 3709) · Ankylosing Spondylitis - disease-level clinical article (ankylosing-spondylitis-referral-clinical.txt)", "review_status": "reviewed", "verified_against": "Naproxen 500 mg Tablets SmPC section 4.2 (eMC product 2639) · eMC SmPC, Arcoxia 90 mg film-coated tablets (Organon), sections 4.1 and 4.2 · Celecoxib US prescribing information, Dosage and Administration (DailyMed SetID 2c86ece8-1cf5-4688-91b1-8aef5d60b7e4) · Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986) · Enbrel 50mg solution for injection in pre-filled syringe SmPC sections 4.1, 4.2 and 4.3 (eMC product 273) · Wenker KJ, Quint JM. Ankylosing Spondylitis. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Bookshelf ID: NBK470173. PMID: 29261996. · Remsima 100 mg powder for concentrate for solution for infusion (infliximab) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 3709) · Ankylosing Spondylitis - disease-level clinical article (ankylosing-spondylitis-referral-clinical.txt)", "verified_date": "2026-08", "treatments": [ { "id": 181, "generic": "Celecoxib", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 200.0, "adult_dose": "200 mg once daily (or 100 mg twice daily); may increase to 200 mg twice daily if symptoms persist", "adult_duration": null, "dose_source": "Celecoxib US prescribing information, Dosage and Administration (DailyMed SetID 2c86ece8-1cf5-4688-91b1-8aef5d60b7e4)", "rationale": "First-line pharmacological therapy for inflammatory back pain and stiffness in axial spondyloarthritis", "cautions": [ "Celecoxib is a COX-2 inhibitor: the GI bleeding risk is lower than with non-selective NSAIDs, but cardiovascular caution is mandatory.", "Avoid in severe hepatic or renal impairment.", "Avoid the use of celecoxib capsules in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Child >=2 years for juvenile idiopathic arthritis: 50 mg BID (10-25 kg) or 100 mg BID (>25 kg)", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": [ { "label": "2 years and over", "age_min_months": 24, "age_max_months": 216, "dose_text": "For juvenile idiopathic arthritis: 50 mg twice daily (10 to 25 kg) or 100 mg twice daily (over 25 kg)." } ], "peds_doses": null, "brands": [ { "trade_name": "RHEUMAMAX 200MG 20 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "HI-PHARM", "price_egp": 52.0, "pack_count": 20, "unit_price": 2.6, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CELOXIB 200MG 10 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SEDICO", "price_egp": 28.8, "pack_count": 10, "unit_price": 2.88, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ARYTHREX 200MG 20 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMOUN", "price_egp": 94.0, "pack_count": 20, "unit_price": 4.7, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CELECOX 200MG 10 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MEMPHIS", "price_egp": 49.0, "pack_count": 10, "unit_price": 4.9, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CELEBORG 200 MG 20 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "BORG", "price_egp": 99.0, "pack_count": 20, "unit_price": 4.95, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "EUROCOX 200MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EUROPEAN EGYPTIAN PHARM. IND.", "price_egp": 67.0, "pack_count": 10, "unit_price": 6.7, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CELEBREX 200MG 10 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PFIZER > VIATRIS EGYPT", "price_egp": 132.0, "pack_count": 10, "unit_price": 13.2, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CELEBREX 200MG 15 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PFIZER > VIATRIS EGYPT", "price_egp": 198.0, "pack_count": 15, "unit_price": 13.2, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ankylosing-spondylitis-referral" }, { "id": 182, "generic": "Naproxen", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 500.0, "adult_dose": "500 mg twice daily with food continuously while inflammatory symptoms persist", "adult_duration": null, "dose_source": "Naproxen 500 mg Tablets SmPC section 4.2 (eMC product 2639)", "rationale": "Non-selective NSAID alternative preferred when cardiovascular risk is a concern", "cautions": [ "Co-prescribe PPI gastroprotection for continuous long-term use.", "Urgent rheumatology referral is required for biologic disease-modifying anti-rheumatic drugs (TNF inhibitors / IL-17 inhibitors)." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not recommended under 16 years for this indication - the product label restricts paediatric naproxen to juvenile idiopathic arthritis (10 mg/kg/day in two divided doses, child over 5 years). Use paracetamol or ibuprofen instead.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "ORGOPROXEN 500 MG 20 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ORGANOPHARMA > ORGANO", "price_egp": 16.0, "pack_count": 20, "unit_price": 0.8, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NAPROSYN 500 MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MISR > F.HOFFMAN LA ROCHE", "price_egp": 8.05, "pack_count": 10, "unit_price": 0.81, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NAPROFEN 500MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL NILE.", "price_egp": 12.0, "pack_count": 10, "unit_price": 1.2, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NAPROFEN 500MG 20 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL NILE.", "price_egp": 24.0, "pack_count": 20, "unit_price": 1.2, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ankylosing-spondylitis-referral" }, { "id": 183, "generic": "Etoricoxib", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": 60.0, "adult_dose": "60 mg once daily; may be increased to 90 mg once daily if 60 mg gives insufficient relief. The dose for ankylosing spondylitis must not exceed 90 mg daily", "adult_duration": "Use the lowest effective dose for the shortest time consistent with symptom control, and review the need to continue at every visit", "dose_source": "eMC SmPC, Arcoxia 90 mg film-coated tablets (Organon), sections 4.1 and 4.2", "rationale": "67 live products - the second-largest orphan on the list after esomeprazole. Ankylosing spondylitis is a named SmPC indication with its own dose ceiling, and this condition had two free slots. A COX-2 inhibitor causes less gastroduodenal injury than the naproxen already listed, which matters when an NSAID is taken continuously for years.", "cautions": [ "CONTRAINDICATED in established ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.", "CONTRAINDICATED in uncontrolled hypertension - blood pressure persistently above 140/90 mmHg. Measure it before starting and again within two weeks, and treat the hypertension before the arthritis.", "Contraindicated in active peptic ulceration or gastrointestinal bleeding, and in severe hepatic dysfunction.", "Do not combine with the celecoxib or naproxen already in this row, and do not add to low-dose aspirin without a PPI.", "The reduced gastrointestinal risk versus a traditional NSAID does not come with any cardiovascular advantage - thrombotic risk rises with dose and duration.", "Nephrotoxicity including interstitial nephritis and nephrotic syndrome - check renal function in an older patient or one on an ACE inhibitor or diuretic." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Contraindicated in children and adolescents under 16 years of age.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "RECOXITRO 60 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MARCYRL PHARMACEUTICAL INDUSTRIES (MPI)", "price_egp": 147.0, "pack_count": 30, "unit_price": 4.9, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "RUMAXIMAP 60 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 147.0, "pack_count": 30, "unit_price": 4.9, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ETICOXIA 60 MG 14 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "HIKMA PHARMA", "price_egp": 69.0, "pack_count": 14, "unit_price": 4.93, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "WINZOXIB 60 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AL ESRAA PHARMACEUTICAL OPTIMA", "price_egp": 189.0, "pack_count": 30, "unit_price": 6.3, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ROCOXAR 60 MG 21 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL DELTA FOR PHARMACEUTICAL INDUSTRIES > DELTA PHARMA", "price_egp": 159.0, "pack_count": 21, "unit_price": 7.57, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "COXRITOR 60 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLOBAL NAPI PHARMACEUTICALS > GLOBAL PHARMACEUTICAL INDUSTRIES", "price_egp": 282.0, "pack_count": 30, "unit_price": 9.4, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TORIXAVA 60 MG 10 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EUROPEAN EGYPTIAN PHARM. IND.", "price_egp": 108.0, "pack_count": 10, "unit_price": 10.8, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ARCOXIA 60 MG 14 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MERCK SHARP & DOHME", "price_egp": 224.0, "pack_count": 14, "unit_price": 16.0, "strength_mg": 60.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ankylosing-spondylitis-referral" }, { "id": 184, "generic": "Adalimumab", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": null, "adult_dose": "Subcutaneous, one standard dose. SmPC verbatim: \"The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.\"", "adult_duration": "Reviewed at 12 weeks. SmPC verbatim: \"Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.\" The disease article sets the same clock: \"the response to TNF-Is should be evaluated after 12 weeks.\"", "dose_source": "Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986)", "rationale": "The disease article names the step and the drug, verbatim: \"If NSAIDs do not provide adequate relief, they can be combined with or substituted for tumor necrosis factor inhibitors (TNF-Is) such as adalimumab, infliximab, or etanercept.\" The SmPC's indication section names the disease, verbatim: \"Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.\" Rheumatology starts it; the card carried NSAIDs alone, which is the first half of the article's own sentence. Nine Egyptian adalimumab products are registered.", "cautions": [ "Screen for tuberculosis and treat active infection before the first dose. Anyone on a TNF antagonist catches serious infection more readily than they otherwise would, and the SmPC therefore wants a close watch kept for infection - tuberculosis included - ahead of treatment, while it runs, and once it has finished. Egypt is a country where latent tuberculosis is common, so this screen is not a formality.", "Contraindicated outright in some patients: tuberculosis that is active, any other severe infection - sepsis among them - and the opportunistic infections; also heart failure at NYHA class III or IV, that is moderate through to severe.", "Hold during an acute infection. Do NOT start Humira while an infection is active - a chronic or a localised one counts - and wait until that infection is under control.", "Systemic steroids are not the alternative here. A glucocorticoid given systemically is NOT advised for ankylosing spondylitis; injecting a steroid locally is a different matter, and in particular cases it can be weighed up." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not a paediatric prescription in this disease. Humira's paediatric spondyloarthritis licence is enthesitis-related arthritis from 6 years, which is a different indication with its own weight-based dose - a child with inflammatory back pain goes to paediatric rheumatology, not onto an adult regimen.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "ADALIMAB-EIPICO 40 MG/0.8ML PREFILLED SYRINGE", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RELIANCE LIFE SCIENCES > EIPICO", "price_egp": 4675.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ADALIMAB-EVA 40 MG/0.4ML 2 PREFILLED SYRINGE", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ALVOTECH > EVA PHARMA", "price_egp": 7000.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "HYRIMOZ 40MG/0.8ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANDOZ > NOVARTIS PHARMA SANDOZ DIVISION", "price_egp": 8435.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AMGEVITA 40MG/0.8ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMGEN MANUFACTURING LIMITED > AMGEN SCIENTIFIC OFFICE", "price_egp": 11680.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "HULIO 40MG/0.8ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "TERUMO > ONE PHARMA MEDICS", "price_egp": 11680.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "HUMIRA 40MG/0.4ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ABBVIE LTD. > MULTIPHARMA", "price_egp": 14113.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ankylosing-spondylitis-referral" }, { "id": 185, "generic": "Etanercept", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": null, "adult_dose": "Subcutaneous. SmPC verbatim, for \"Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis\": \"The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.\"", "adult_duration": "Reviewed at 12 weeks. SmPC verbatim: \"For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.\"", "dose_source": "Enbrel 50mg solution for injection in pre-filled syringe SmPC sections 4.1, 4.2 and 4.3 (eMC product 273)", "rationale": "The disease article names it, verbatim: \"If NSAIDs do not provide adequate relief, they can be combined with or substituted for tumor necrosis factor inhibitors (TNF-Is) such as adalimumab, infliximab, or etanercept.\" The SmPC's indication section names the disease, verbatim: \"Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.\" Etanercept sits beside adalimumab as an equal option, which is how the article writes it. Egypt registers four products - ENBREL 25 mg and 50 mg, and the biosimilar ERELZI at roughly a third of the price.", "cautions": [ "Screen for infection before and during treatment. The SmPC wants every patient assessed for infection ahead of Enbrel, throughout it, and afterwards - bearing in mind that etanercept takes a mean of roughly 70 hours to be eliminated by half. Latent tuberculosis is common in Egypt and must be excluded first.", "Contraindicated outright in some patients: sepsis, or any risk of it. And Enbrel is NOT begun while an infection is active, whether that infection is chronic or confined to one place.", "Record the brand and batch at every injection. So that a biological can be traced, the SmPC asks for the product's brand name and its batch number to be written plainly into the notes each time one is given. Biosimilars are not interchangeable without a record of which was given.", "Systemic steroids are not the alternative here. A glucocorticoid given systemically is NOT advised for ankylosing spondylitis; injecting a steroid locally is a different matter, and in particular cases it can be weighed up." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not a paediatric prescription in this disease. Enbrel's paediatric licences are juvenile idiopathic arthritis, adolescent psoriatic arthritis, enthesitis-related arthritis and paediatric plaque psoriasis; ankylosing spondylitis is written for adults.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "ERELZI 25 MG 4 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "NOVARTIS PHARMA > SANDOZ", "price_egp": 3277.0, "pack_count": null, "unit_price": null, "strength_mg": 25.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ERELZI 50 MG 4 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "NOVARTIS PHARMA > SANDOZ", "price_egp": 5409.0, "pack_count": null, "unit_price": null, "strength_mg": 50.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ENBREL 25 MG 4 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PFIZER", "price_egp": 8904.0, "pack_count": null, "unit_price": null, "strength_mg": 25.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ENBREL 50 MG 4 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PFIZER", "price_egp": 14985.0, "pack_count": null, "unit_price": null, "strength_mg": 50.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ankylosing-spondylitis-referral" }, { "id": 186, "generic": "Infliximab", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": null, "adult_dose": "Intravenous infusion, dosed by body weight. SmPC verbatim: \"5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks.\"", "adult_duration": "Stopped early if the first two doses do nothing. SmPC verbatim: \"If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with infliximab should be given.\" The disease article sets a longer clock for the class - \"the response to TNF-Is should be evaluated after 12 weeks.\"", "dose_source": "Remsima 100 mg powder for concentrate for solution for infusion (infliximab) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 3709)", "rationale": "The disease article names the step and the drug, verbatim: \"If NSAIDs do not provide adequate relief, they can be combined with or substituted for tumor necrosis factor inhibitors (TNF-Is) such as adalimumab, infliximab, or etanercept.\" The SmPC's indication section names the disease, verbatim: \"Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.\" It is the third of the article's three named TNF inhibitors and the only one the card lacked. Rheumatology starts it. Egypt registers one infliximab product, REMICADE 100 mg powder for intravenous infusion at roughly 5,900 EGP a vial, and a course is several vials per infusion at adult body weights.", "cautions": [ "RED FLAG - tuberculosis is excluded before the first infusion, not after it. Every patient is assessed for tuberculosis ahead of infliximab, the active disease and the dormant ('latent') kind alike, and the screening is done in all of them: a tuberculin skin test, a chest X-ray, an interferon gamma release assay, or some combination of those. The SmPC also warns that most of the cases reported sat outside the lungs. Latent tuberculosis is common in Egypt, so this is a real gate rather than a formality.", "Infection risk runs for months after the last infusion. Watch closely for infection, tuberculosis included, before infliximab, during it and afterwards; clearing the drug can take as long as six months, and the watching carries on that whole time. If a serious infection or sepsis develops, infliximab must NOT be given again. A blunted fever is part of the hazard - damping TNF down can hide the signs of infection, fever among them.", "Contraindicated outright in some patients: tuberculosis, or another severe infection - sepsis, an abscess, an opportunistic organism; and heart failure at NYHA class III or IV, moderate or severe.", "An intravenous hospital drug, not a prescription pad drug. The infusion is given by qualified staff trained to spot trouble arising from it, because infliximab has caused acute reactions during infusion - anaphylactic shock among them - as well as hypersensitivity that comes on late.", "Systemic steroids are not the alternative here. A glucocorticoid given systemically is NOT advised for ankylosing spondylitis; injecting a steroid locally is a different matter, and in particular cases it can be weighed up." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not a paediatric prescription in this disease. SmPC verbatim: \"The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.\" A child with inflammatory back pain goes to paediatric rheumatology.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "REMICADE 100 MG PD. VIAL FOR I.V. INF. 10 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "JANSSEN CILAG > SOFICOPHARM", "price_egp": 5936.0, "pack_count": null, "unit_price": null, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ankylosing-spondylitis-referral" } ] }